Device recalls
Recall records from FDA, newest initiation date first.
Every device recall MDM has ingested. The recall record supplies the product, the reason and the product code; the matching enforcement report supplies the Class I, II or III classification. Where the two have not been joined, the class is left blank rather than assumed.
Data as of , the FDA export date. FDA medical device recall database
| Recall number | Class | Product | Recalling firm | Product code | Initiated |
|---|---|---|---|---|---|
| Z-0783-2007 | B.Braun HyperFormer Pump Dispensing Set, Catalog Number V9900-02. The product is shipped... | B Braun Medical Inc | LHI | ||
| Z-1070-2007 | Total B-hCG Speciment Diluent is composed of 1 bottle of Total B-hCG Specimen Diluent... | Abbott Diagnostic International, Ltd. | JHI | ||
| Z-1069-2007 | IMx Total B-hCG Reagent is composed of one bottle of Anti B-hCG Coated Microparticles... | Abbott Diagnostic International, Ltd. | JHI | ||
| Z-1068-2007 | AxSYM Total B-hCG Reagent List 7A59-22 is composed of one bottle of Anti B-hCG Coated... | Abbott Diagnostic International, Ltd. | JHI | ||
| Z-1067-2007 | AxSYM Total B-hCG Reagent List 7A59-21 is composed of one bottle of Anti B-hCG Coated... | Abbott Diagnostic International, Ltd. | JHI | ||
| Z-0742-2007 | Disposable Bimanuals Irrigation and Aspiration Handpiece Set: Item #1721 Disposable... | Oasis Medical, Inc. | KYG | ||
| Z-0741-2007 | Disposable Bimanuals Irrigation and Aspiration Handpiece Set: Item #1720 Disposable... | Oasis Medical, Inc. | KYG | ||
| Z-0740-2007 | Disposable Bimanuals Irrigation and Aspiration Handpiece Set: Item #1719 Disposable... | Oasis Medical, Inc. | KYG | ||
| Z-0813-2007 | BD 5ml Syringe Luer-Lok Tip Bulk Sterile Convenience Pak Latex Free | Becton Dickinson & Co | FMF | ||
| Z-0840-2007 | Smith & Nephew, 420XL Xenon Light Source, 180 Watt; for endoscopic use. Catalog/Part... | Smith & Nephew, Inc. | FFS | ||
| Z-0767-2007 | Miltex Stainless Steel Disposable Scalpel #22, Part Number 4-422. Each box contains 10... | Miltex, Inc. | GES | ||
| Z-0817-2007 | Medtronic Buffer Solution pH 1.07 500ml REF 9012D1071 Manufactured by/for Medtronic A/S... | Medtronic Neuromodulation | JCC | ||
| Z-1101-2008 | UniCel DxC 800 PRO Part Number: A10407, Beckman Coulter, Inc. | Siemens Healthcare Diagnostics Inc. | JJE | ||
| Z-1100-2008 | UniCel DxC 800 Part Number: A10411, Beckman Coulter, Inc. | Siemens Healthcare Diagnostics Inc. | JJE | ||
| Z-1099-2008 | UniCel DxC 600 PRO Part Number: A10400, Beckman Coulter, Inc. | Siemens Healthcare Diagnostics Inc. | JJE | ||
| Z-1098-2008 | UniCel DxC 600i, Part Numbers: A25638, A25639, Beckman Coulter, Inc. | Siemens Healthcare Diagnostics Inc. | JJE | ||
| Z-1097-2008 | UniCel DxC 600 Part Number: A10405, Beckman Coulter, Inc. | Siemens Healthcare Diagnostics Inc. | JJE | ||
| Z-1096-2008 | Synchron LXi 725, Part Number A08357, Beckman Coulter, Inc. | Siemens Healthcare Diagnostics Inc. | JJE | ||
| Z-1095-2008 | Synchron LX20 PRO, Part Number 476100, Beckman Coulter, Inc. | Siemens Healthcare Diagnostics Inc. | JJE | ||
| Z-1094-2008 | Synchron LX20 Clinical Chemistry System, Part Numbers: 466200,473032, Beckman Coulter... | Siemens Healthcare Diagnostics Inc. | JJE | ||
| Z-1525-2008 | FACSDiva Software Versions 4.0.1 to 5.0.2, Flow Cytometry Acquisition & Analysis... | Becton, Dickinson and Company, BD Biosciences | GKZ | ||
| Z-0839-2007 | Silver Speed Hydrophilic Guidewire, for placement of vascular catheters. Model #... | Medtronic, Inc. | MKI | ||
| Z-0918-2007 | Roche Online TDM Tobramycin, for use on Roche/Hitachi analyzers 917 and Modular P... | Roche Diagnostics GmbH | KLB | ||
| Z-0917-2007 | Roche Online TDM Tobramycin, for use on Roche/Hitachi analyzers 911,912, 917 and Modular... | Roche Diagnostics GmbH | KLB | ||
| Z-0873-2007 | Light Source 300 Watt Xenon Lamp used in the following models: Viking EndoSite Xenon... | ConMed Corporation | KOG | ||
| Z-0809-2007 | Product is an EO Sterile, Polydioxanone Violet monofilament synthetic absorbable surgical... | C P Medical Inc. | GAM | ||
| Z-0808-2007 | Product is an EO Sterile, Blue Polypropylene monofilament synthetic nonabsorbable... | C P Medical Inc. | GAW | ||
| Z-0807-2007 | Product is an EO Sterile, Polyester braided and coated nonabsorbable surgical suture with... | C P Medical Inc. | GAT | ||
| Z-0754-2007 | RITA Starburst MRI SemiFlex (3-5 cm Diameter/25cm Length), Electro-surgical Device... | Boston Scientific Corporation | GEI | ||
| Z-0753-2007 | RITA StarBurst (2-3cm Diameter/25cm Length), Electro-surgical Device, Manufactured by... | Boston Scientific Corporation | GEI | ||
| Z-0752-2007 | RITA Starburst XL (3-5 cm Diameter/25cm Length), Electro-surgical Device, Manufactured... | Boston Scientific Corporation | GEI | ||
| Z-1437-2010 | Diopsys Inc., Enfant Pediatric VEP Vision Testing System, Input: 120 Vac, 60Hz/2.5A IEC... | Diopsys Inc | GWE | ||
| Z-1190-2007 | Volcano s5 Imaging system, Ultrasound pulsed echo imaging system. Product consists of... | Volcano Corporation | IYO | ||
| Z-1076-2007 | Ossur Total Knee Model Number 2100, external knee prosthesis. | Ossur Iceland ehf. | ISY | ||
| Z-0980-2007 | Proximate PPH, Procedure for Prolapse and Hemmorroids Set, REF PPH03. Each set contains... | Ethicon Endo-Surgery Inc | GDW | ||
| Z-0772-2007 | Lumex Walkabout Lite Four-Wheel Rollator, Manufactured for: Graham-Field Health Products... | GF Health Products, Inc. | ITJ | ||
| Z-2136-2012 | Class I | Radiological Image Processing System The system is an aid to locate anatomical... | GE Healthcare | LLZ | |
| Z-1109-2007 | Thoratec Paracorporeal Ventricular Assist Device (PVAD) component of the Thoratec VAD... | Abbott Medical | DSQ | ||
| Z-0079-2008 | Intuitive Surgical, daVinci S Surgical System, Model Number: IS2000, A5.1 P1 and A5.0 P5... | Intuitive Surgical, Inc. | NAY | ||
| Z-1165-2007 | One Touch SureSoft Lancing Device in carton. Part Number 021-140-01, aka OT SureSoft... | Lifescan, Inc. | FMK | ||
| Z-1071-2007 | NEFA Standard Solution Calibrator, Oleic Acid, 1 mmol/L, 4x10mL bottles per carton, Cat... | FUJIFILM Healthcare Americas Corporation | JIT | ||
| Z-1202-2007 | Abbott AxSYM System Digoxin III Reagent Pack | Abbott Diagnostic International, Ltd. | KXT | ||
| Z-0979-2007 | STA Neoplastine CI Plus (10), (cat. 0667). 12 x 10 ml. in vitro diagnostic for the... | Diagnostica Stago, Inc. | GJS | ||
| Z-0887-2007 | Batteries used with the LIFEPAK 20 defibrillator/monitor | Physio Control, Inc. | MJK | ||
| Z-0769-2007 | Magnetom Espree System with OR Table | Siemens Medical Solutions USA, Inc. | LNH | ||
| Z-0886-2007 | LIFEPAK 20 defibrillator/monitor. The device is an AC powered defibrillator device with... | Physio Control, Inc. | MJK | ||
| Z-1713-2008 | GE Healthcare Proteus XR/a Eclipse Collimator model # 2379827. | GE Healthcare | KPR | ||
| Z-1169-2007 | Microlab F.A.M.E. reagent containers, Part number 148482, box containing 48 containers... | Hamilton Co | JQW | ||
| Z-0175-2008 | Rascal Scooters with Electric seat lifts, Model 600 Series, distributed between... | Electric Mobility | INI | ||
| Z-0067-2011 | SoftPath GUI Releases 3.17 through 4.1.0. SCC Soft Computer 5400 Tech Data Drive... | SCC Soft Computer | LNX |